An Observational Registry Using Drug Eluting Stents (DES) in Patients in a Real-World Setting (DEScover Registry). (DESCOVER)

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00489320
First received: June 20, 2007
Last updated: August 1, 2007
Last verified: August 2007

June 20, 2007
August 1, 2007
December 2004
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Complete list of historical versions of study NCT00489320 on ClinicalTrials.gov Archive Site
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An Observational Registry Using Drug Eluting Stents (DES) in Patients in a Real-World Setting (DEScover Registry).
An Observational Registry Using Drug Eluting Stents (DES) in Patients in a Real-World Setting (DEScover Registry).

The DEScover Registry is designed to observe the results of using Drug Eluting Stents (DES) in patients in a real-world setting. The stents being observed are not investigational, that is, they have been approved for use in the general population.

The D.E.S.cover Registry is a prospective, multi-center, observational study. Consecutive patients undergoing PCI procedures will be asked to consent to participate in this study. For these patients, baseline, clinical and angiographic characteristics, as well as certain procedural and clinical events will be recorded using standardized case report forms. Outcomes will be assessed during hospitalization and at one, six and twelve months after discharge. Depending on results from the first year of follow-up, the study may be extended with an additional one or two years of follow-up.

The strategy for achieving the scientific objectives of the Registry is to document actual, real-world PCI practice and outcomes. Accordingly, the D.E.S.cover Registry does not specify treatment protocols, require any particular assignment of patients to treatment protocols, or in any other way require participating physicians to alter their practice patterns. Participating physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on the parameters and outcomes of this treatment to the D.E.S.cover Registry database.

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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  • Cardiovascular Diseases
  • Vascular Disease
  • Arterial Occlusive Disease
  • Arteriosclerosis
  • Atherosclerosis
Device: Cypher Stent
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Williams DO, Abbott JD, Kip KE; DEScover Investigators. Outcomes of 6906 patients undergoing percutaneous coronary intervention in the era of drug-eluting stents: report of the DEScover Registry. Circulation. 2006 Nov 14;114(20):2154-62. Epub 2006 Oct 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7759
July 2006
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Inclusion Criteria:

  • Consecutive patients undergoing percutaneous coronary intervention at an enrolling center by study investigators

Exclusion Criteria:

  • Patient refusal or inability to provide written informed consent and/or HIPAA authorization
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00489320
DESCOVER
No
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Cordis Corporation
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Principal Investigator: David O Williams Rhode Island Hospital
Cordis Corporation
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP